The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Accessory Irrigation Adapter.
| Device ID | K162142 |
| 510k Number | K162142 |
| Device Name: | Accessory Irrigation Adapter |
| Classification | Endoscope Channel Accessory |
| Applicant | WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD Winston-salem, NC 27105 |
| Contact | Theresa De Prat |
| Correspondent | Theresa De Prat WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD Winston-salem, NC 27105 |
| Product Code | ODC |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-01 |
| Decision Date | 2017-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002319028 | K162142 | 000 |